红景天含量测定能力验证结果评价与分析

Evaluation and Analysis of Proficiency Testing for Salidroside Determination in Rhodiolae Crenulatae Radix et Rhizoma

目的提高云南省药品生产企业及其他相关检测机构的检测能力和质量管理水平。方法根据中国合格评定国家认可委员会相关文件要求,设计“样品对”方案验证各实验室的红景天含量测定能力,检验样品A、B、C、D的均匀性和稳定性。采用稳健统计方法分析报道结果,以实验室间和实验室内Z比分数(Z_(B)和Z_(W))评价检测结果。结果117家参试实验室,115家报送结果(Z_(B)为-2.91~11.39,ZW为-5.82~16.02),90家结果满意,整体满意率78.26%,样品对AB及样品对CD的结果满意率相当(78.33%比78.18%)。结论云南省大部分实验室具备红景天含量测定的检测能力,建议相关实验室加强人员培训、质量监督和质量控制,以提升机构的检测能力和质量管理水平。

Objective To improve the testing capability and quality management level of pharmaceutical manufacturing enterprises and other relevant testing institutions in Yunnan Province.Methods According to the requirements of the relevant documents of the China National Accreditation Service for Conformity Assessment,the proficiency testing for salidroside determination in Rhodiolae Crenulatae Radix et Rhizoma of relevant laboratories was performed based on the″sample pairs″scheme,and the uniformity and stability of samples A,B,C,and D were tested.The submitted data were analyzed by the robust statistical method,and the testing results were evaluated based on the inter-laboratory and intra-laboratory Z-scores(Z_(B)and Z_(W)).Results Out of 117 participating laboratories,115 submitted data(ZB was in the range of-2.91-11.39,Z_(W)was in the range of-5.82-16.02);90 laboratories achieving satisfactory outcomes,with an overall satisfaction rate of 78.26%;the satisfaction rates for sample pair AB and sample pair CD were comparable(78.33%vs.78.18%).Conclusion The majority of laboratories in Yunnan Province demonstrated the capability to determine the salidroside content in Rhodiolae Crenulatae Radix et Rhizoma.It is recommended that relevant laboratories strengthen personnel training,quality supervision and quality control to improve their testing capability and quality management level.